Standard Operating Procedure for Maintenance of Centrifuges

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of centrifuges in pharmaceutical manufacturing facilities to ensure efficient and safe separation processes.

2) Scope

This SOP applies to all centrifuges used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Centrifuge Technician or designated personnel are responsible for the maintenance and operation of centrifuges.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for centrifuges based on manufacturer recommendations and operational requirements.
   2. Inspect centrifuge components such as rotor, lid, bearings, and seals regularly for wear, corrosion, or imbalance.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing centrifuge components to prevent cross-contamination and ensure product purity.
   2. Use approved cleaning agents and methods suitable for centrifuge materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure centrifuge operates within specified parameters such as speed, temperature, and g-force.
   2. Calibrate centrifuge speed and temperature controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for centrifuge malfunctions, spills, or other incidents.
   2. Train personnel on emergency shutdown procedures and containment protocols.
5. Documentation and Reporting
   1. Maintain accurate records of centrifuge inspections, maintenance activities, performance tests, and calibration results.
   2. Document any incidents, repairs, or adjustments made to the centrifuge system.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Sanitization Procedures, Performance Verification Reports, Emergency Procedures Manual, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for centrifuge maintenance, industry guidelines for separation processes, regulatory requirements for equipment sanitation, and local safety regulations.

8) SOP Version

Version 1.0